The US Food and Drug Administration (FDA) has granted orphan drug status to Abraxane, to support development of the treatment to fight pancreatic cancer as well as stage IIB-IV melanoma.
The Office of Orphan Products Development of the FDA granted orphan drug designation to Abraxane, developed by Abraxis BioScience, as a chemotherapy agent Injectable Suspension (paclitaxel protein-bound particles for injectable suspension).
Orphan drug designation is granted to support the development of new treatments for rare and difficult diseases for which there is a small market.
Abraxis BioScience president and chief executive officer Lonnie Moulder said that the company was looking forward to the potential of bringing a new treatment option to patients with these difficult-to-treat cancers.
Enrollment is at Phase III of a study to evaluate Abraxane as a first-line therapy for advanced metastatic pancreatic cancer. A Phase III registration study comparing ABRAXANE to dacarbazine in stage IV chemotherapy naïve melanoma patients is also actively enrolling.